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Optimising processes requires more than attention to detail. It requires strategic foresight. Our aim is to work with you to develop solutions that help you in the short term and achieve your goals in the long term.
Feasible, pragmatic – yet tailored to help you succeed.

Quality Management & GMP

Pharmaceutical Quality System
GMP Compliance & Assessment
Quality Risk Management
Knowledge Management

Drug Regulatory Affairs

Designing Quality in Drug Development
Marketing Authorisation
Post-Approval Changes
Technology Transfer
Scientific-Technical Documentation
Authority Meetings

Publishing - eCTD

eSubmission – it all starts with a project plan
Preliminary PDF Checks
STFs, Datasets, BIMO, Cross Application References, …
eCTD Support or Full Service
Customized Employee Training

“We cannot direct the wind.
But we can adjust the sails.“

Bertha Calloway

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